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Article ; Online: Evolut R and Evolut PRO vs. Sapien 3 for transcatheter aortic valve implantation - The 'generation gap' and beyond.

Gozdek, Mirosław / Kowalewski, Mariusz

2023 Volume 398, Page(s) 131647

MeSH term(s)	Humans ; Transcatheter Aortic Valve Replacement ; Aortic Valve/diagnostic imaging ; Aortic Valve/surgery ; Aortic Valve Stenosis/surgery ; Heart Valve Prosthesis ; Prosthesis Design ; Treatment Outcome ; Postoperative Complications
Language	English
Publishing date	2023-12-10
Publishing country	Netherlands
Document type	Letter
ZDB-ID	779519-1
ISSN	1874-1754 ; 0167-5273
ISSN (online)	1874-1754
ISSN	0167-5273
DOI	10.1016/j.ijcard.2023.131647
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Article ; Online: Long-term mortality after percutaneous coronary intervention with drug-eluting stents compared with coronary artery bypass grafting for multivessel and left main disease: a meta-analysis.

Kowalewski, Mariusz / Gozdek, Mirosław / Zieliński, Kamil / Raffa, Giuseppe M / Suwalski, Piotr / Lorusso, Roberto

Kardiologia polska

2020 Volume 78, Issue 7-8, Page(s) 759–761

MeSH term(s)	Coronary Artery Bypass ; Coronary Artery Disease/surgery ; Drug-Eluting Stents/adverse effects ; Humans ; Percutaneous Coronary Intervention ; Treatment Outcome
Language	English
Publishing date	2020-05-28
Publishing country	Poland
Document type	Journal Article ; Meta-Analysis
ZDB-ID	411492-9
ISSN	1897-4279 ; 0022-9032
ISSN (online)	1897-4279
ISSN	0022-9032
DOI	10.33963/KP.15397
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Article ; Online: Posterior pericardial drainage by any means may improve outcomes after cardiac surgery.

Kowalewski, Mariusz / Gozdek, Mirosław / Hagner, Wojciech / Anisimowicz, Lech

The Journal of thoracic and cardiovascular surgery

2017 Volume 154, Issue 2, Page(s) 512–514

MeSH term(s)	Cardiac Surgical Procedures ; Drainage ; Humans ; Pericardiocentesis ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2017-03-24
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	3104-5
ISSN	1097-685X ; 0022-5223
ISSN (online)	1097-685X
ISSN	0022-5223
DOI	10.1016/j.jtcvs.2017.04.063
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Article ; Online: Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes.

Milan, Joanna / Gozdek, Mirosław / Targoński, Radosław / Kowalewski, Mariusz / Stańska, Aleksandra / Fijałkowski, Marcin / Lango, Romuald / Jaguszewski, Miłosz / Jagielak, Dariusz

Cardiology journal

2021 Volume 28, Issue 6, Page(s) 825–830

Abstract: Background: The NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1- ... ...

Abstract	Background: The NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1-year results of the trial are presented. Methods: Twenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak. Results: Patients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak. Conclusions: The current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.
MeSH term(s)	Aged ; Aortic Valve/diagnostic imaging ; Aortic Valve/surgery ; Aortic Valve Stenosis/diagnostic imaging ; Aortic Valve Stenosis/surgery ; Bioprosthesis ; Female ; Heart Valve Prosthesis ; Humans ; Prosthesis Design ; Stroke ; Terfenadine/analogs & derivatives ; Transcatheter Aortic Valve Replacement/adverse effects ; Treatment Outcome
Chemical Substances	Terfenadine (7BA5G9Y06Q) ; fexofenadine (E6582LOH6V)
Language	English
Publishing date	2021-09-07
Publishing country	Poland
Document type	Journal Article ; Observational Study
ZDB-ID	2488680-4
ISSN	1898-018X ; 1897-5593
ISSN (online)	1898-018X
ISSN	1897-5593
DOI	10.5603/CJ.a2021.0093
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Article ; Online: Outcomes of Transcatheter Aortic Valve Implantation Comparing Medtronic's Evolut PRO and Evolut R: A Systematic Review and Meta-Analysis of Observational Studies.

Gozdek, Mirosław / Kuźma, Łukasz / Dąbrowski, Emil Julian / Janiak, Michał / Pietrzak, Martyna / Skonieczna, Karolina / Woźnica, Mikołaj / Wydeheft, Lidia / Makhoul, Maged / Matteucci, Matteo / Litwinowicz, Radosław / Kowalówka, Adam / Wańha, Wojciech / Pasierski, Michał / Ronco, Daniele / Massimi, Giulio / Jiritano, Federica / Fina, Dario / Martucci, Gennaro /

Raffa, Giuseppe Maria / Suwalski, Piotr / Lorusso, Roberto / Meani, Paolo / Kowalewski, Mariusz

International journal of environmental research and public health

2023 Volume 20, Issue 4

Abstract: Background: Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and ... ...

Abstract	Background: Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes. Methods: A systematic review and meta-analysis was carried out to compare Medtronic's Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed. Results: Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age ( Conclusions: The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.
MeSH term(s)	Humans ; Transcatheter Aortic Valve Replacement ; Prosthesis Design ; Postoperative Complications/etiology ; Treatment Outcome ; Aortic Valve Stenosis/complications ; Aortic Valve Stenosis/surgery ; Hemorrhage/complications ; Risk Factors
Language	English
Publishing date	2023-02-15
Publishing country	Switzerland
Document type	Meta-Analysis ; Systematic Review ; Journal Article ; Review
ZDB-ID	2175195-X
ISSN	1660-4601 ; 1661-7827
ISSN (online)	1660-4601
ISSN	1661-7827
DOI	10.3390/ijerph20043439
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Article ; Online: Comparative performance of transcatheter aortic valve-in-valve implantation versus conventional surgical redo aortic valve replacement in patients with degenerated aortic valve bioprostheses: systematic review and meta-analysis.

Gozdek, Miroslaw / Raffa, Giuseppe Maria / Suwalski, Piotr / Kolodziejczak, Michalina / Anisimowicz, Lech / Kubica, Jacek / Navarese, Eliano Pio / Kowalewski, Mariusz

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery

2018 Volume 53, Issue 3, Page(s) 495–504

Abstract: The objective of this report was to directly compare, by means of a systematic review and meta-analysis, redo surgical aortic valve replacement (re-sAVR) with valve-in-valve transcatheter aortic valve implantation (ViV TAVI) for patients with failed ... ...

Abstract	The objective of this report was to directly compare, by means of a systematic review and meta-analysis, redo surgical aortic valve replacement (re-sAVR) with valve-in-valve transcatheter aortic valve implantation (ViV TAVI) for patients with failed degenerated aortic bioprostheses. Multiple databases were screened for all available reports comparing ViV TAVI with re-sAVR in patients with failing degenerated aortic bioprostheses. The primary outcome was all-cause mortality determined from the longest available survival data. Five observational studies (n = 342) were included in the meta-analysis; patients in the ViV TAVI group were older and had a higher baseline risk compared to those in the re-sAVR group. Although there was no statistical difference in procedural mortality [risk ratio (RR) 0.74, 95% confidence interval (CI) 0.18-2.97; P = 0.67], 30-day mortality (RR 1.29, 95% CI 0.44-3.78; P = 0.64) and cardiovascular mortality (RR 0.91, 95% CI 0.30-2.70; P = 0.86) at a mean follow-up period of 18 months, cumulative survival analysis favoured surgery with borderline statistical significance (ViV TAVI versus re-sAVR: hazard ratio 1.91, 95% CI 1.03-3.57; P = 0.039). ViV TAVI was associated with a significantly lower rate of permanent pacemaker implantations (RR 0.37, 95% CI 0.20-0.68; P = 0.002) and shorter intensive care unit (P < 0.001) and hospital stays (P = 0.020). In contrast, re-sAVR offered superior echocardiographic outcomes: lower incidence of patient-prosthesis mismatch (P = 0.008), fewer paravalvular leaks (P = 0.023) and lower mean postoperative aortic valve gradients in the prespecified analysis (P = 0.017). The ViV TAVI approach is a safe and feasible alternative to re-sAVR that may offer an effective, less invasive treatment for patients with failed surgical aortic valve bioprostheses who are inoperable or at high risk. Re-sAVR should remain the standard of care, particularly in the low-risk population, because it offers superior haemodynamic outcomes with low mortality rates.
MeSH term(s)	Aged ; Aged, 80 and over ; Aortic Valve/surgery ; Bioprosthesis/adverse effects ; Bioprosthesis/statistics & numerical data ; Female ; Heart Valve Prosthesis/adverse effects ; Heart Valve Prosthesis/statistics & numerical data ; Humans ; Male ; Middle Aged ; Postoperative Complications ; Reoperation/adverse effects ; Reoperation/methods ; Reoperation/statistics & numerical data ; Transcatheter Aortic Valve Replacement/adverse effects ; Transcatheter Aortic Valve Replacement/methods ; Transcatheter Aortic Valve Replacement/statistics & numerical data ; Treatment Outcome
Language	English
Publishing date	2018-01-24
Publishing country	Germany
Document type	Comparative Study ; Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	639293-3
ISSN	1873-734X ; 1010-7940 ; 1567-4258
ISSN (online)	1873-734X
ISSN	1010-7940 ; 1567-4258
DOI	10.1093/ejcts/ezx347
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Article ; Online: Mortality benefit after reinforced reduction aortoplasty for dilated ascending aorta. Meta-analysis.

Gozdek, Mirosław / Kowalewski, Mariusz / Ruchalski, Michał / Malvindi, Pietro Giorgio / Anisimowicz, Lech

International journal of cardiology

2015 Volume 199, Page(s) 50–52

MeSH term(s)	Aorta, Thoracic/surgery ; Aortic Aneurysm, Thoracic/mortality ; Aortic Aneurysm, Thoracic/surgery ; Global Health ; Humans ; Reconstructive Surgical Procedures/methods ; Survival Rate/trends ; Vascular Surgical Procedures/methods
Language	English
Publishing date	2015-11-15
Publishing country	Netherlands
Document type	Letter ; Meta-Analysis
ZDB-ID	779519-1
ISSN	1874-1754 ; 0167-5273
ISSN (online)	1874-1754
ISSN	0167-5273
DOI	10.1016/j.ijcard.2015.07.015
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Article ; Online: Transcathether aortic valve implantation with the new repositionable self-expandable Medtronic Evolut R vs. CoreValve system: evidence on the benefit of a meta-analytical approach.

Kowalewski, Mariusz / Gozdek, Mirosław / Raffa, Giuseppe Maria / Słomka, Artur / Zieliński, Kamil / Kubica, Jacek / Anisimowicz, Lech / Kowalewski, Janusz / Landes, Uri / Kornowski, Ran / Lorusso, Roberto / Suwalski, Piotr

Journal of cardiovascular medicine (Hagerstown, Md.)

2019 Volume 20, Issue 4, Page(s) 226–236

Abstract: Aims: To compare transcatheter aortic valve replacement TAVR with self-expandable first-generation Medtronic CoreValve with new-generation Evolut R devices in patients with aortic stenosis.: Methods: Multiple databases were screened for all available ...

Abstract	Aims: To compare transcatheter aortic valve replacement TAVR with self-expandable first-generation Medtronic CoreValve with new-generation Evolut R devices in patients with aortic stenosis. Methods: Multiple databases were screened for all available reports directly or indirectly comparing CoreValve vs Evolut R. Primary endpoint was device success. Procedural, functional and clinical outcomes were assessed as well. Results: Ten retrospective series including 12 294 pts. were found. Overall device success rate was 95.5% and was statistically higher in the Evolut R treated patients as compared with CoreValve: 96.6 vs. 94.8%, respectively; RR (risk ratio) 95%CIs (confidence intervals): 1.02 (1.00-1.04); P = 0.01. There were no statistical differences with regard to postoperative mean aortic gradients 8.5 +/- 5.3 vs 7.9 +/- 4.6 with Evolut R and CoreValve. Evolut R valve demonstrated nearly 50% reduction of the risk for moderate-to-severe paravalvilar leak 0.55 (0.39-0.79); P = 0.001; 60% statistically significant lower risk of developing myocardial injury 0.40 (0.22-0.72); P = 0.002 and numerical reductions in the risk of acute kidney injury, vascular complications and bleeding. Together with significantly reduced risk of permanent pacemaker implantation (0.80 [0.67-0.96]; P = 0.02) the above benefits were associated with 40% reduction in the risk of 30-day all-cause mortality with Evolut R as compared to CoreValve: 0.60 (0.37-1.00); P = 0.05. Conclusions: The use of new-generation Evolut R was associated with improved procedural, functional and clinical outcomes compared with the CoreValve device.
MeSH term(s)	Aged ; Aged, 80 and over ; Aortic Valve/diagnostic imaging ; Aortic Valve/physiopathology ; Aortic Valve/surgery ; Aortic Valve Stenosis/diagnostic imaging ; Aortic Valve Stenosis/mortality ; Aortic Valve Stenosis/physiopathology ; Aortic Valve Stenosis/surgery ; Female ; Heart Valve Prosthesis ; Humans ; Male ; Postoperative Complications/etiology ; Prosthesis Design ; Recovery of Function ; Risk Factors ; Time Factors ; Transcatheter Aortic Valve Replacement/adverse effects ; Transcatheter Aortic Valve Replacement/instrumentation ; Transcatheter Aortic Valve Replacement/mortality ; Treatment Outcome
Language	English
Publishing date	2019-03-04
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	2223461-5
ISSN	1558-2035 ; 1558-2027
ISSN (online)	1558-2035
ISSN	1558-2027
DOI	10.2459/JCM.0000000000000757
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Zs.A 5210: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Transcatheter aortic valve replacement with Lotus and Sapien 3 prosthetic valves: a systematic review and meta-analysis.

Journal of thoracic disease

2020 Volume 12, Issue 3, Page(s) 893–906

Abstract: Background: Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with early-generation devices and focused technological improvements. Current systematic review and meta-analysis sought ... ...

Abstract	Background: Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with early-generation devices and focused technological improvements. Current systematic review and meta-analysis sought to compare outcomes of TAVR for severe native valve stenosis with next-generation devices: Lotus and Sapien 3. Methods: Electronic databases were screened for studies comparing outcomes of TAVR with Lotus and Sapien 3. In a random-effects meta-analysis, the pooled incidence rates of procedural, clinical and functional outcomes according to VARC-2 definitions were assessed. Results: Eleven observational studies including 2,836 patients (Lotus N=862 Conclusions: Lotus valve, as compared with Sapien 3, was associated with lower risk for PVL but higher risk for permanent pacemaker implantation and cerebrovascular events.
Language	English
Publishing date	2020-05-11
Publishing country	China
Document type	Journal Article
ZDB-ID	2573571-8
ISSN	2077-6624 ; 2072-1439
ISSN (online)	2077-6624
ISSN	2072-1439
DOI	10.21037/jtd.2019.12.107
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Article: Transcatheter Aortic Valve Replacement with Self-Expandable ACURATE neo as compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-analysis of Randomized and Propensity-Matched Studies.

Gozdek, Mirosław / Zieliński, Kamil / Pasierski, Michał / Matteucci, Matteo / Fina, Dario / Jiritano, Federica / Meani, Paolo / Raffa, Giuseppe Maria / Malvindi, Pietro Giorgio / Pilato, Michele / Paparella, Domenico / Słomka, Artur / Kubica, Jacek / Jagielak, Dariusz / Lorusso, Roberto / Suwalski, Piotr / Kowalewski, Mariusz

Journal of clinical medicine

2020 Volume 9, Issue 3

Abstract: The authors sincerely apologise for the imperfections made during the collection of the data and wish to make the following corrections to this paper [ ... ]. ...

Abstract	The authors sincerely apologise for the imperfections made during the collection of the data and wish to make the following corrections to this paper [...].
Language	English
Publishing date	2020-03-20
Publishing country	Switzerland
Document type	Published Erratum
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm9030861
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